Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reported: July 30, 2025 Initiated: June 18, 2025 #Z-2143-2025
Product Description
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason for Recall
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 11 units
- Distribution
- International distribution to the country of Japan.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.. Recalled by Olympus Corporation of the Americas. Units affected: 11 units.
Why was this product recalled? ▼
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 30, 2025. Severity: Moderate. Recall number: Z-2143-2025.
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